a pilot study of apligraf for the treatment and prevention of recurrence of excised keloids

Conditions: Keloid

Summary: this pilot study will assess the safety and efficacy of apligraf in the healing and recurrence of keloids post surgical shave excision in patients with clinically diagnosed keloids.


Eligibility criteria:
inclusion criteria: * subject is between 18 and 65 years of age. * subject or legal guardian has read, understood, and signed appropriate institutional review board (irb) approved informed consent, photography release form and hipaa consent in their own language. * subject with 1 keloid measuring between 1 cm2 - 40 cm2 as assessed by the investigator, present for at least 6 months and a beausang scar scale combined score of 5 or greater. * subject is a male or female who must have a documented negative urine pregnancy test if of child bearing potential. sexually active females must be practicing a medically proven form of contraception during the course of the study period. * subject and/or legal guardian must be able and willing to follow study procedures and instructions. * subject and/or legal guardian must be able and willing to return for follow-up study visits. * subject agrees to not use a keloid medication or injection treatment for four weeks prior to day 0. * subject agrees not to use any other keloid treatments for the duration of the study. * subject is otherwise healthy as assessed and determined by the investigator exclusion criteria: * subject is suffering from a condition likely to require medical attention, including administration of any treatment which in the opinion of the investigator could influence the results of the study. * subject with any systemic condition like uncontrolled diabetes mellitus (glycosylated hemoglobin, hba1c \> 10%), cancer (biopsy confirming active malignancy), positive hiv test, or any disorder(s) that may compromise wound healing. * subject is suffering from an abnormal skin condition on the affected area not usually associated with keloids such as psoriasis, or eczema. * subject who is currently or has received topical or systemic steroid medication therapy within the past four weeks affecting the course of the keloid and/or its evaluability. inhaled steroid therapy is acceptable. * subject with the presence of acute infections in the areas intended for treatment. * subject with known hypersensitivity to bovine collagen or to the components of the apligraf agarose shipping medium. * subject who is lactating or pregnant (positive result as determined by urine testing). * subject with liver (alt/sgpt, alp, ast/sgot, bilirubin, albumin, total protein, ldh) and/or renal function (bun and creatinine) tests \> 2 x upper limit of normal (uln). * subject who has been previously enrolled in any wound or investigational device study for any disease within the past four weeks. * subject who has received an investigational drug or biological treatment within the past three months. * subject previously treated with apligraf, dermagraft or any other cell therapy at the target keloid site. * subject with a history of alcohol or substance abuse within the previous year, which could interfere with study compliance such as inability to attend scheduled study visits or compliance with home dressing changes. * subject with a history of anaphylaxis. * subject who, in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol